What is "human subjects research review"?

Federal and state regulations, as well as CWU policy, require that any use of human participants in research be reviewed and approved by an institutional review board (IRB). The Human Subjects Review Council (HSRC) serves as the institutional review board for Central Washington University. The university's Human Protections Administrator coordinates the work of the HSRC and is located in Black Hall 225-17 (963-3115).

How do I know if my research project requires institutional (i.e., HSRC) review?

Any CWU faculty member, staff member, or student whose investigation involves either the collection of data from human participants or the use of personal records must submit a research proposal for HSRC review.

If you are using already existing data in your research, please refer to " Archival Data Checklist" for further guidance.

Do student research projects require institutional review and approval?

Any student research project with human participants conducted as part of an independent study course, undergraduate honors thesis, undergraduate directed research (e.g., SOURCE), or master's thesis/project must be submitted for HSRC review and approval.

I am on a tight timeline to get my research done. How long does the HSRC review process take?

The amount of time required for the HSRC to review your study and notify you of the status of your proposal varies depending upon the type of review required, the clarity and completeness of the application, and the number of reviews being conducted by the HSRC at the same time. If your proposal is truly exempt from formal HSRC review and your application is complete, you will likely receive written notification from the human protections administrator within three weeks. Alternately, if your research proposal meets the criteria for a "minimal risk review" by a subcommittee of the HSRC, the review and notification process may take up to 6 weeks. Additional time may be required for clarifications and/or revisions. Finally, should the nature of your planned research require formal review at a convened meeting of the HSRC, the approval process time could take up to eight weeks. Please note that the review and approval process may take longer when proposals are submitted near the end of a quarter, during quarter breaks, or in cases where an investigator's application materials are incomplete.

Whom should I contact for more information about the HSRC review and approval process?

The CWU human protections administrator (HPA) coordinates the day-to-day activities of the Human Subjects Review Council (HSRC). The HPA is available for individual consultation with researchers who are preparing either requests for exemptions or applications for HSRC review and approval. Please click here for HSRC contact information.

Which forms do I use when submitting my research proposal for HSRC review and approval?

Initially, when you submit your research proposal for HSRC review, you should select one of two options. After carefully reviewing the criteria for exemption from formal HSRC review (see above) and/or consulting with the HSRC office, if you believe your research qualifies for exemption, you should submit the "Request for Exemption" form to the human protections administrator. If your study does not meet one or more of the exemption criteria, you should submit the full "Human Subjects Review Council Application" form. Even if you believe your study is exempt from formal HSRC review, you must submit an exemption request form and receive the human protections administrator's certification of your exemption prior to initiating your research.

The most common error made by investigators is failure to download the most recent version of the needed form from the Forms and Templates page. Cutting and pasting on a previously used application form (or within the Application Help Manual) may delay review of your application.

Why are there so many different forms for HSRC approval?

Good question! Federal regulations concerning the conduct of research with human participants require that institutions not only review and approve an investigator's initial study proposal, but they also require that research protocols be reviewed on a continuing basis. Furthermore, if an investigator wants to make changes in previously approved study procedures, these modifications are also subject to HSRC review and approval. Finally, there may be occasions in which unanticipated problems occur during the course of a study; in all cases, these events must be reported to the HSRC in keeping with the federal requirements for human research. HSRC provides a form for each of these occasions.

What factors do HSRC members consider when reviewing my research proposal?

The HSRC reviews the proposed purpose(s), procedures, and participant populations to be used in order to determine whether the benefits of the research activity outweigh the anticipated risks to subjects. Among the issues to be considered are:

how participants are approached (i.e., recruited) to be in the study;

what procedures are used to obtain consent from prospective participants or their legally authorized representatives;

the type of compensation, if any, offered to participants;

the safeguards in place to protect participants who may be vulnerable to coercion or undue influence;

the procedures used to protect participants' privacy; and

the nature of the physical and psychosocial risks, stresses, and discomforts participants will be asked to endure.

Is it possible that the HSRC will deny approval of my research proposal?

On occasion, the HSRC may decide there is insufficient information to approve or disapprove a human subjects research application. In such a case, the HSRC will defer consideration of the proposal and, instead, will ask the researcher to clarify or provide additional information. When the HSRC receives this additional information from the investigator, the application is reconsidered for approval.

In very rare instances, an institutional review board (IRB) like the CWU Human Subjects Review Council may determine that the risks of a proposed study outweigh the anticipated benefits and will consequently withhold council approval of the investigation. Should the researcher disagree with the HSRC disapproval of the study, the decision may be appealed using procedures specified by the institution.

However, the more typical case is that the investigator and the HSRC will choose to work together to modify study-related procedures in order to reduce the risks to participants, and in turn, gain council approval to commence with the research.

Once I have received HSRC approval, how long is it valid?

In keeping with the federal regulations, HSRC approval of reviewed research is valid for no more than one year. (On rare occasions, the HSRC may determine that a study requires continuing review more frequently than every 12 months.) A few weeks before your study's approval expires, you will receive a "Status Report" form from the human protections administrator. You should use this form to notify the HSRC of the current status of your research project. If the approved investigation has been completed, the HSRC should also be notified of its completion; however, if you intend to continue recruiting participants or collecting data, a "Request for Continuing Approval" form should be submitted at least four weeks prior to your study's expiration date.

If your initial application for HSRC approval was determined "Exempt" from formal HSRC review, institutional approval of your study is granted for a period of between one to five years so long as your approved study procedures are not modified in any way.

If I am collecting data on-line (using the Internet), what additional information should I submit?

Data collection using the Internet (e-mail, web-based surveys, chat rooms, etc.) presents unique issues of security, privacy, and the informed consent process that are not easily resolved. If using a web-based survey, refer to Survey Research Requirements. For other Internet data collection, it is advisable to call the HSRC office for guidance.

If I am collecting data off-campus, do I need to get permission or approval from anyone other than the HSRC?

Researchers seeking access to participants through other agencies or institutions should fully inform these organizations about the purposes and procedures of the planned research. Official approval from a designated representative of the organization must be obtained and included with the materials you submit for HSRC review and approval. A sample letter of cooperation is available on the Forms and Templates page. No participants may be recruited from these agencies or institutions until these organizations and the HSRC have approved your research proposal.

Investigators who wish to conduct research in other countries should consult with the HSRC regarding specific procedures for obtaining local (i.e., host community, country), approval of the research protocol.

If I am using copyright materials or other instruments not authored by me, what must I do?

It is the usual practice of the HSRC to ask investigators to document the sources of instruments they are using. For each instrument not authored by the investigator, include evidence that permission has been granted from the author to use this instrument in its original or modified form. This may take the form of copies of correspondence (letters or emails) with an author which clearly states that the investigator has permission to use or modify the instrument before using it in this research.

With respect to copyright or licensed materials, it is expected that CWU investigators will purchase these materials in sufficient quantities appropriate to their study sample size and will not photocopy them for use by subjects. Include with your application a statement or receipt for purchase of copyrighted or licensed materials. Please note: If more than one purchased instrument is submitted to the HSRC in the review/approval process, the extras will be returned to the investigator at the conclusion of the review.

Is a consent form always required when collecting data from human participants?

Federal regulations governing human subjects research allow for circumstances in which the requirements for written documentation of informed consent may be waived by the institutional review board (i.e., the CWU Human Subjects Review Council). In addition to reviewing these regulations, you may find it helpful to consult with the human protections administrator prior to submitting your application for HSRC review.

Speaking of consent forms, what exactly should be included in the informed consent form?

Great question! The Office for Human Research Protections (OHRP) offers very helpful guidance concerning the content of informed consent documents. In addition, a consent form checklist has also been developed to assist investigators in evaluating their consent forms prior to HSRC review.

Investigators planning research with minors (i.e., children) should also consider developmentally-appropriate procedures for gaining the assent of these study participants in addition to acquiring the informed consent of their parent or legal guardian. Sample consent, assent, and parental permission forms are available on the Forms and Templates page.

What if I want to change some of my study procedures after the HSRC has already approved my research?

You must notify the HSRC if you intend to make changes in your research protocol. You can make minor and administrative changes (e.g., change in location, change in recruitment procedures, minor change in design) by submitting a "Project Modification Request Form" to the HSRC. However, if you intend to make substantial changes in the purpose, design, procedures, or participants of your research, you may be required to submit a new "HSRC Application" form. Please contact the human protections administrator if you have questions about the types of protocol changes that will require submission of a new application rather than a "Project Modification Request Form."